This survey has been designed as a multinationalcollaboration to collect data from several countries focusing ondeveloping countries. The main purpose was to elaborate thefunctions of ethics committees regarding externally-sponsoredresearch . In March 2004 a total of 89 open-endedquestionnaires were sent to ethics review committees inmedical schools, medical research institutes and hospitalsaffiliated to the public and private medical universities inJapan.Twenty two ECs replied , and among them five ECshad reviewed eleven ESR proposals in 2002-3. Five of thoseESR proposals have been (...) approved and four proposals havebeen approved after some revisions. Two proposals weredeferred but not resumed. In their review, respondents weremore concerned about “individual consent” than “communityconsent”. Post-trial access to effective interventions was not areal concern. As for “Standard of care”, seven ECs replied thatthey review the ESR proposal based on the internationalstandards and four based on the local standards. WhetherESR proposal is matched with the national health prioritieswas not a great concern. Respondents expressed theirconcern about socio-cultural issues.Ethics in research especially dealing with externallysponsoredresearch is a relatively new subject and underdevelopment in Japan. Although Japan is not a developingcountry, in order to protect individual human subjects and localcommunity, capacity building in ethics review especially inresearch collaboration with other developed and developingcountries is crucial and it has to be included in ethics inresearch programs through out the country. (shrink)

In his paper entitled “Ethics and the Funding of Research and Development at Universities”1 Spier examines some of the potential problems of the relationship between 1) corporate sponsors of research and 2) the universities (and faculty) that receive that funding. Citing “He who pays the piper, calls the tune,” Spier suggests that a better way of funding research would be to “set up a dedicated publicly sponsored research establishment” with the stated goal of achieving particular (...) technical or engineering objectives. (Spier cited the successful Animal Virus Research of the UK as an example). Spier states that researchers at these establishments are “not subjected to the triple requirement to teach, research and administer as are university members, so they do not have to face the same ethical challenges of the academics.” This paper will examine the stated dangers of public/corporate research partnerships and whether the proposed alternative shares equally troubling ethical issues. (shrink)

Simple type theory is a higher-order predicate logic for reasoning about truth values, individuals, and simply typed total functions. We present in this paper a version of simple type theory, called PF*, in which functions may be partial and types may have subtypes. We define both a Henkin-style general models semantics and an axiomatic system for PF*, and we prove that the axiomatic system is complete with respect to the general models semantics. We also define a notion of an interpretation (...) of one PF* theory in another. PF* is intended as a foundation for mechanized mathematics. It is the basis for the logic of , an Interactive Mathematical Proof System developed at The MITRE Corporation. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Fallout from Government-Sponsored Radiation ResearchCarol Mason Spicer (bio)On December 28, 1993, Energy Secretary Hazel R. O'Leary publicly appealed to both the executive and legislative branches of the United States Government to consider compensation for individuals who were harmed by their exposure to ionizing radiation while enrolled in government-sponsored studies conducted between 1940 and the early 1970s.1 The call for compensation was issued three weeks after Secretary O'Leary (...) disclosed that radiation experiments involving humans, sometimes without their consent, had occurred under the auspices of the Atomic Energy Commission (AEC), a forerunner of the Department of Energy (DOE). Secretary O'Leary directed her department to investigate the nature and extent of the experiments, report on their medical and ethical acceptability, and locate the research subjects or their families.Background to the Federal Advisory CommitteeDespite the fact that the existence of many government-sponsored radiation experiments was not a secret—much of the research was reported at the time in scientific journals, and in 1986, Representative Edward J. Markey (D-MA) conducted congressional hearings on such radiation research—Secretary O'Leary's disclosure of the AEC experiments and her call for compensation made the experiments common knowledge and sparked a swift and complex governmental response involving both the executive and legislative branches.It is curious that the "radiation experiments" have garnered so much attention now, since they were virtually ignored in the wake of the 1986 hearings. Secretary O'Leary's disclosure of the radiation studies grew out of a general reassessment of secrecy in government. In April 1993, the Clinton administration set out to review the system of government secrecy that evolved during the Cold War, and in May 1993, DOE began reviewing and declassifying files pertaining to nuclear weapons research. When Dan Reicher, a top aide to Secretary O'Leary, informed her in November of the impending publication of an Albuquerque Tribune investigative report (Welsome 1993) on an experiment conducted between 1945 and 1947 in which 18 subjects were injected with plutonium, [End Page 147] the topic of questionable research involving the exposure of human subjects to radiation was added to the DOE list of information to be disclosed. At the time, it was thought to be but one small part of a massive quantity of DOE information to be made public.As part of its effort to investigate the radiation experiments, DOE established a toll-free telephone hot line for individuals who thought they might have been the subjects of radiation exposure experiments. The hot line, originally staffed by three people to handle the anticipated few dozen calls per day, received more than 2,000 calls in the first week. By early January the hot line was flooded with 6,000 to 10,000 calls daily, and its staff had increased more than ten-fold. Although many of the calls were deemed not to be candidates for further investigation, the extent of the radiation-related experiments, sponsored not only by AEC, but also by the military and other government departments and agencies, took officials by surprise.On December 30, the Department of Defense, the Department of Veterans Affairs, and the National Aeronautics and Space Administration all announced that they were initiating thorough reviews of their files to determine the extent and nature of any radiation experiments conducted under their auspices.2 In January, the CIA and the Department of Health and Human Services, including the National Institutes of Health, followed suit.The White House publicly entered the arena in late December announcing that it would hold a meeting on January 3, 1994, to help coordinate the government's investigative effort. At the same time, Senator Edward M. Kennedy (D-MA) called for a mid-January congressional hearing to investigate experiments conducted between 1946 and 1956 in which mentally retarded boys at the Fernald State School in Massachusetts were fed radioactive iron supplements or milk containing radioactive calcium to enable researchers to trace the absorption of those nutrients. Senator Kennedy's hearing, conducted by the Subcommittee on Health of the Senate Committee on Labor and Human Resources, was the first of a number of congressional hearings held earlier this year to investigate the... (shrink)

Private industry funds more than half of all medical research in the United States. While industry involvement in research has benefits, it can also create conflicts of interest. The most common policies adopted to address conflict of interest in medical research are focused primarily on the ways in which industry sponsorship may undermine a clinician’s judgment regarding patient care. Insufficient attention has been given to the ways in which industry sponsorship may undermine judgment relative to the goal (...) of scientific integrity in research. The most common conflict of interest policies do not adequately address this problem. Disclosure policies alone will not remove or ameliorate all conflicts. Further, severing or monitoring ties between clinicians and industries will not adequately address the problem, since in many cases it is not the clinicians who are making the relevant research judgments. In order to address the problem of conflict of interest inindustry-sponsored research, fundamental changes in strategy and practice must be adopted which either remove the power to make research decisions from industry employees, or increase the review of those decisions by independent investigators. (shrink)

Background:Data representing people’s behaviour, attitudes, feelings and relationships are increasingly being harvested from social media platforms and re-used for research purposes. This can be ethically problematic, even where such data exist in the public domain. We set out to explore how the academic community is addressing these challenges by analysing a national corpus of research ethics guidelines and published studies in one interdisciplinary research area.Methods:Ethics guidelines published by Research Councils UK, its seven-member councils and guidelines cited (...) within these were reviewed. Guidelines referring to social media were classified according to published typologies of social media research uses and ethical considerations for social media mining. Using health research as an exemplar, PubMed was searched to identify studies using social media data, which were assessed according to their coverage of ethical considerations and guidelines.Results:Of the 13 guidelines published or recom... (shrink)

Globalization, political upheavals, and Western economic struggles have caused a geographical reprioritization in the realm of drug development and human clinical research. Regulatory and cost hurdles as well as a saturation of research sites and subjects in Western countries have forced the pharmaceutical industry to place an unprecedented level of importance on emerging markets, injecting Western corporate initiatives into cultures historically and socially isolated from Western-centric value systems. One of the greatest recipients of this onslaught of Western business (...) and research practices is the Russian Federation. Namely, market forces are dictating a focused research initiative in the traditional emerging markets, but this focus may be at the expense of individual and societal dignity. (shrink)

Increasingly, US-sponsored research is carried out in developing countries, but how US Institutional Review Boards (IRBs) approach the challenges they then face is unclear.METHODS: I conducted in-depth interviews of about 2 hours each, with 46 IRB chairs, directors, administrators and members. I contacted the leadership of 60 IRBs in the United States (US) (every fourth one in the list of the top 240 institutions by National Institutes of Health (NIH) funding), and interviewed IRB leaders from 34 (55%).RESULTS: US (...) IRBs face ethical and logistical challenges in interpreting and applying principles and regulations in developing countries, given economic and health disparities, and limited contextual knowledge. These IRBs perceive wide variations in developing world IRBs/RECs' quality, resources and training; and health systems in some countries may have long-standing practices of corruption. These US IRBs often know little of local contexts, regulations and standards of care, and struggle with understandings of other cultures' differing views of autonomy, and risks and benefits of daily life. US IRBs thus face difficult decisions, including how to interpret principles, how much to pay subjects and how much sustainability to require from researchers. IRB responses and solutions include trying to maintain higher standards for developing world research, obtain cultural expertise, build IRB infrastructure abroad, communicate with foreign IRBs, and ‘negotiate’ for maximum benefits for participants and fearing ‘worst-case scenarios’.CONCLUSIONS: US and foreign IRBs confront a series of tensions and dilemmas in reviewing developing world research. These data have important implications for increased education of IRBs/RECs and researchers in the US and abroad, and for research and practice. (shrink)

The present research is the first part of econometric study of the so called sponsored goods and looks at one of the most common types of such goods namely art products created by theaters, concert organizations and museums. The aim of the paper is to analyse the performance of Russian art organizations to find out to what extend the conditions of their functioning in post Soviet times under the development of market economy, democratization of leisure and changes in (...) consumer preferences influence their economic results. Could Russian theaters, museums and concert organizations be self- sufficient in market economy established in Russian in 1991-2010?The set up task determined the object of the study and the statistical data to be used-40 years time series performance indicators that include equal time intervals-1971-1990 for performing arts organizations and 1991-2010-for theaters, concert organizations and museums. The specifics of calculations presented in the article result from the very approach to the testing of cost disease. Its essence is to reveal the symptoms of this disease in art organizations taken as an element of economy as a whole rather than only as a part of cultural activities. Accordingly a new method of diagnostics of the cost disease is suggested that is based on development of specific indexes measuring the lag of labor productivity, advancing dynamics of wages and priority growth in prices for tickets in relation to the corresponding indexes of macroeconomic dynamics as well as determination of cost disease consequences-the deficit of income of providers of cultural goods. The implementation of such an approach allowed to construct three-dimensional space which coordinates describe the dynamics of performance results of art organizations. (shrink)

A volume of studies in natural language semantics which brings together work by philosophers, logicians and linguists. The main topics treated are: quantification and reference in natural language; the relations between formal logic, programming languages and natural language; pragmatics and discourse meaning; surface syntax and logical meaning. The volume derives from a colloquium organised in 1973 by the Kings College Research Centre, Cambridge and the papers have been edited for publication by Professor Keenan. It is hoped that the collection (...) will make available some of the best work in this fast-moving field and will stimulate further progress by juxtaposing the different approaches and interests represented here. (shrink)

Individual and institutional conflict of interests in biomedical research have becomes matters of increasing concern in recent years. In the United States, the growth in relationships — sponsored research agreements, consultancies, memberships on boards, licensing agreements, and equity ownership — between for-profit corporations and research universities and their scientists has made the problem of conflicts, particularly financial conflicts, more acute. Conflicts can interfere with or compromise important principles and obligations of researchers and their institutions, e.g., adherence (...) to accepted research norms, duty of care to patients, and open exchange of information. Disclosure is a key component of a successful conflict policy. Commitments which conflict with a faculty member's primary obligations to teaching, research, administrative responsibilities, or patient care also need attention. Institutional conflict of interests present different problems, some of which are discussed in an analysis of an actual problem posed by two proposed clinical trials. (shrink)

Government-sponsored enterprises (GSEs) and quasi-autonomous non-governmental organizations (quangos) comprise a powerful organizational sector that has been criticized for its lack of accountability to governments and their citizens. These organizations are established to serve the public as a whole by targeting the needs of particular groups or fulfilling specific functions. Often they use practices adopted from the business sector, and sometimes they enter the marketplace as profitmaking enterprises. In light of the contribution of GSE Fannie Mae to the 2008 world (...) economic crisis, the impact of this sector on effective democratic government bears further examination. In this article, I present a systems model that suggests how researchers might comprehensively assess the accountability of organizations in this sector, here termed the "gray sector," with respect to their government missions. I focus on four systems dimensions: mission, organizational design, organizational outcomes, and the information feedback process. Organizational design and the nature of the sector population are cited as emerging issues of particular importance. (shrink)

In this case study from litigation, we show how ghostwriting of clinical trial results can contribute to the manipulation of data to favor the study medication. Study 329 for paroxetine pediatric use was negative for efficacy and positive for harm. Yet the ghostwritten publication from this study concluded that paroxetine provided evidence of efficacy and safety and continues to be influential. Despite the role of named authors in revisions of the manuscript, the sponsor company remained in control of the message.

International research, sponsored by for-profit companies, is regularly criticised as unethical on the grounds that it exploits research subjects in developing countries. Many commentators agree that exploitation occurs when the benefits of cooperative activity are unfairly distributed between the parties. To determine whether international research is exploitative we therefore need an account of fair distribution. Procedural accounts of fair bargaining have been popular solutions to this problem, but I argue that they are insufficient to protect against (...) exploitation. I argue instead that a maximin principle of fair distribution provides a more compelling normative account of fairness in relationships characterised by extreme vulnerability and inequality of bargaining potential between the parties. A global tax on international research would provide a mechanism for implementing the maximin account of fair benefits. This model has the capacity to ensure fair benefits and thereby prevent exploitation in international research. (shrink)

Contributed research papers presented in UGC sponsored National Seminar on "God and the Universe: Religious and Scientific Approaches" organized by the Department of Sanskrit, Mugberia Gangadhar Mahavidyalaya, Purba Medinipur, West Bengal on 22nd and 23rd November, 2016.

Projects may exist in many forms, depending on the purpose and organisational context. Irrespective of the type and nature, however, the effective management of any project requires a high degree of commitment by the project members to the accomplishment of project objectives. The high degree of reliance on external international funding makes project management in non-profit organisations of developing societies a challenging task. The marriage of two entirely different sets of values and philosophical orientations creates an invisible tensile force, impacting (...) the different stages of the project life cycle. The present paper, which is exploratory in nature, broadly aims to study the impact of sponsors’ values on the different project-management activities, including both the planning and the implementation stages of the project. The research involves conceptualisation of the different significant issues in effective project management. The analysis of the identified issues is first made on the basis of the experience of the selected stakeholders in Tanzanian non-profit organisations. The analysis is further linked to the selected context-specific contemporary philosophical thoughts affecting the socio-cultural values in the region. The analysis shows that the variation in the values of project owners and stakeholders is one of the major challenges in the effective implementation of a project in the given context. The study is novel in its approach and raises some fundamental issues arising due to the different philosophical orientations and value-sets of the different partner-project organisations. It is expected that the study will stimulate further academic debate on the broader theme of ‘values, philosophy and project management’. The study is also likely to contribute to knowledge development in the subject area of management in general and practical management philosophy in particular. (shrink)

Discussions on the ethics and regulation of clinical research have a great deal to say about the responsibilities of investigators, sponsors, research institutions and institutional review boards, but very little about the responsibilities of research participants. In this article, we discuss the responsibilities of participants in clinical research. We argue that competent adult participants are responsible for complying with study requirements and fulfilling other obligations they undertake when they make an informed choice to enrol in a (...) study. These responsibilities are based on duties related to promise-keeping, avoiding harm to one's self or others, beneficence and reciprocity. Investigators and research staff should inform participants about their responsibilities during the consent process, and should stress the importance of fulfilling study requirements. They should address any impediments to compliance, and they may provide participants with financial incentives for meeting study requirements. In very rare cases, coercive measures may be justified to prevent immanent harm to others resulting from non-compliance with study requirements. (shrink)

In a military-sponsored research project begun during the Second World War, inmates of the Stateville Penitentiary in Illinois were infected with malaria and treated with experimental drugs that sometimes had vicious side effects. They were made into reservoirs for the disease and they provided a food supply for the mosquito cultures. They acted as secretaries and technicians, recording data on one another, administering malarious mosquito bites and experimental drugs to one another, and helping decide who was admitted to (...) the project and who became eligible for early parole as a result of his participation. Thus, the prisoners were not simply research subjects; they were deeply constitutive of the research project. Because a prisoner’s time on the project was counted as part of his sentence, and because serving on the project could shorten one’s sentence, the project must be seen as simultaneously serving the functions of research and punishment. Michel Foucault wrote about such ‘mixed mechanisms’ in his Discipline and punish. His shining example of such a ‘transparent’ and subtle style of punishment was the panopticon, Jeremy Bentham’s architectural invention of prison cellblocks arrayed around a central guard tower. Stateville prison was designed on Bentham’s model; Foucault featured it in his own discussion. This paper, then, explores the power relations in this highly idiosyncratic experimental system, in which the various roles of model organism, reagent, and technician are all occupied by sentient beings who move among them fluidly. This, I argue, created an environment in the Stateville hospital wing more panoptic than that in the cellblocks. Research and punishment were completely interpenetrating, and mutually reinforcing. (shrink)

Little research has explored the possible effects of government institutions in emerging economies on ethical reviews of multinational research. We conducted semi-structured, in-depth telephone interviews with 15 researchers, Research Ethics Committees personnel, and a government agency member involved in multinational HIV Prevention Trials Network research in emerging economies. Ministries of Health or other government agencies often play pivotal roles as facilitators or barriers in the research ethics approval process. Government agency RECs reviewing protocols may face (...) particular challenges, as they can lack resources, be poorly organized, have inconsistent review processes and limited expertise, and use differing definitions of national interests, including upholding national reputation and avoiding potential exploitation and stigma of the country's population. The MOH/governmental review body may be affected by power dynamics and politics in study reviews; may consider issues both related and unrelated to research ethics as understood elsewhere; and may prioritize particular diseases, treatments, or interventions over other topics/types of research. Poor communication and deeply-rooted tensions may exist between sponsor and host countries, impeding optimal interactions and reviews. Investigators must understand and plan for the potential effects of governmental agencies on multinational collaborative research, including preserving adequate time for agency review, and contacting these agencies beforehand to address issues that may arise. Better understanding of these issues can aid and advance appropriate global scientific collaboration. (shrink)

Mit Beitragen von: Wolfgang U. Eckart, Christian Bonah, Wolfgang U. Eckart / Andreas Reuland, Alexander Neumann, Peter Steinkamp, Volker Roelcke, Anne ...

The article deals with trust in applied social science research in the light of applied researchers’ increased dependence on project funding. Taking Norway as a case study it shows how the societal organization of research funding has implications for scientific freedom and ultimately for the confidence we have in research. The article gives an account of various ways the sponsors can influence on applied social science research and discusses the legitimacy of different limitations on scientific freedom. (...) The article concludes with proposals for how the challenges to scientific freedom posed by the research funding framework can be addressed structurally, as well as on the level of the research community. (shrink)

The treatment of the control group in externally sponsored clinical trials is the issue of one of the most heated debates in international research ethics. The paradigmatic cases are the mother-to-child HIV-transmission trials that took place in 16 developing countries in 1997, where the control group received a placebo while proven treatment was available in industrialized countries. From this circumstance results the controversy as to whether the sponsor and researchers of externally sponsored trials have to supply a (...) treatment that is usually not available in the host country. From the beginning of the debate the controversial level of treatment has been called “standard of care”. However, besides the disagreement about the quality of the care that has to be supplied, there is as yet no widely accepted clear meaning of this concept. This article examines the fundamental ambiguity of the term and its formal function as an ethical criterion including suggestions on its further use. (shrink)

Background HIV prevention research has been fraught with ethical concerns since its inception. These concerns were highlighted during HIV vaccine research and have been elaborated in microbicide research. A host of unique ethical concerns pervade the microbicide research process from trial design to post-trial microbicide availability. Given the urgency of research and development in the face of the devastating HIV pandemic, these ethical concerns represent an enormous challenge for investigators, sponsors and Research Ethics Committees (...) (RECs) both locally and internationally. Discussion Ethical concerns relating to safety in microbicide research are a major international concern. However, in the urgency to develop a medically efficacious microbicide, some of these concerns may not have been anticipated. In the risk-benefit assessment of research protocols, both medical and psycho-social risk must be considered. In this paper four main areas that have a potential for medical and/or psycho-social harm are examined. Male partner involvement is controversial in the setting of covert use of microbicides. However, given the long-term exposure of men to experimental products, this may be methodologically, ethically and legally important. Covert use of microbicides may impact negatively on relationship dynamics leading to psychosocial harm to varying extents. The unexpectedly high rates of pregnancy during clinical trials raise important methodological and ethical concerns. Enrollment of adolescents without parental consent generates ethical and legal concerns that must be carefully considered by RECs and trial sites. Finally, paradoxical outcomes in recent trials internationally have advanced the debate on the nature of informed consent and responsibility of researchers to participants who become HIV positive during or after trials. Summary Phase 3 microbicide trials are an undisputed research and ethical priority in developing countries. However, such trials must be conducted with attention to both methodological and ethical detail. It is imperative that guidelines are formulated to ensure that high ethical standards are maintained despite the scientific urgency of microbicide development. Given the controversy raised by emergent ethical issues during the course of microbicide development, it is important that international consensus is reached amongst the various ethics and regulatory agencies in developing and developed countries alike. (shrink)

Background In their paper “Research approvals iceberg: how a ‘low-key’ study in England needed 89 professionals to approve it and how we can do better” Petrova and Barclay highlight concerns with the health research regulatory environment in the UK. Discussion As long-standing chairs of NHS research ethics committees, researchers, and also academics in research ethics, we are also often frustrated with the regulatory process in the UK. However, we think that Petrova and Barclay’s analysis is misleading (...) because it conflates research ethics with governance and funding processes, thus failing to adequately distinguish between the national coordinating function of the Health Research Authority, local research governance processes, and interactions with research sponsors and/or the Clinical Research Network. (shrink)

This paper explores the legal and ethical concept of human subject research in order to determine whether genetic research with already available biosamples and data falls within this concept. Although the ethical concept seems to have evolved to recognize research based on data as human research, from a supranational legal perspective this form of research is not considered human subject research. Thus human subject research regulations do not apply and therefore do not invoke (...) the requirement of obtaining consent prior to using an individual’s biosample or genetic data in research. Furthermore, it remains ambiguous in both the legal and ethical realm whether the use of biosamples or genetic data without additional links to the individual would invoke the same safeguards as research involving additional or specific identifiers. Seeing that research based on already available biosamples and genetic data is not governed by rules concerning human subject research, the second part of the paper analyses whether any consent requirements apply for the further use of already available bio‐samples or genetic data in research. Whereas further use of biosamples is subject to considerably lax consent requirements under Article 22 of the Oviedo Convention, under the General Data Protection Regulation further use of genetic data might not be subject to a prior consent requirement at all, unless it is stipulated in national laws. When it comes to clinical trials, however, sponsors will have the possibility under Article 28(2) of Regulation 536/2014 to obtain open consent for further use of data in any kind of future research. (shrink)

This paper addresses the growing concern over violation of research ethics in marketing, in particular rights of human subjects in fieldwork, notably the right to informed consent; right to privacy and confidentiality; and right not to be deceived or harmed as a result of participation in a research. The paper highlights the interaction of the three main parties involved in most marketing research: the sponsoring organization (client or user), researcher, and participant in the survey, focusing on researcher’s (...) ethical responsibilities in interacting with human subjects in surveys. The paper stresses the importance of ethical integrity in marketing research and emphasizes the need to establish a universal model for regulatory requirements and well institutionalized practice of ethical research. (shrink)

Issues: We present key aspects of our paper, commissioned by UNAIDS in 2005, entitled, “Revisiting the ethics of HIV prevention research in developing countries.” In 2004 and 2005 we witnessed the closure or suspension of three international clinical trials testing tenofovir in the prevention of HIV infection in high risk groups due to the failure to provide free treatment to those who seroconvert during the conduct of the study. We examine critically moral claims for the provision of treatment to (...) those who seroconvert in HIV prevention trials and ask whether it is a matter of moral obligation or moral negotiation?Description: Using the tools of philosophical and regulatory analysis we examine the moral foundations of research ethics, international regulation, and the contemporary literature in search of valid arguments in support of a moral obligation to treat. Arguments supporting the obligation to provide such treatment are found in a wide variety of documents. These claims are variously rooted in the demand to compensate for research-related injury, maximization of research benefit, justice as reciprocity, and justice as equality.Lessons learned: Our analysis reveals that there is as of yet no robust moral argument supporting a moral obligation to provide treatment to participants in HIV prevention trials who seroconvert. We argue that moral negotiation offers distinct advantages over moral obligation. Moral negotiation finds support in the principle of respect for communities that holds researchers responsible to respect communal values, protect and empower social institutions and abide by the decisions of accepted communal authorities.Recommendations: Moral negotiation, rather than moral obligation, reduces the chance of polarization of positions by inviting trial participants, sponsors, researchers and all other involved parties to the table for discussion. Moral negotiation favors middle ground solutions that fit the specific health needs and priorities of the community in question. (shrink)

This article analyzes recent cases of company-sponsored online experiments with unsuspecting users and discusses the ethical aspects of such experimentation. These cases illustrate a new type of online research where companies modify their algorithms to intentionally misinform or mislead users. Unlike typical forms of A/B testing, where two versions of the same website are presented to different users to evaluate interface changes, algorithm modification is a deeper form of testing where changes in program code induce user deception. Thus, (...) we propose to call this new approach C/D experimentation to distinguish it from the surface-level website evaluation associated with A/B testing. Three aspects raise ethical concerns regarding C/D experimentation: the absence of user consent to participate in research, the presence of intentional deception, and the complete lack of protection for human subjects who partake in privately funded behavioral research. Three recommendations are proposed to address these issues: (i) to develop an ethical code of conduct for subject protection shared by online companies, (ii) to include special provisions for C/D experiments in social networking platforms, and (iii) to create an independent user advocacy board to protect the rights of users who partake in online research conducted in the private sector. (shrink)

According to this paper, respect for informed consent implies that subjects should often be told a good deal more than ethical guidelines explicitly or implicitly require. Unless subjects are informed of the researchers’ personal characteristics, views, and sponsors whenever they would be likely to consider them significant, their autonomy is being overridden. However, overriding subjects’ autonomy is sometimes required by the interests of researchers in not being discriminated against or suffering intrusions into their privacy. This paper resolves the conflict between (...) informed consent and the interests of researchers by recommending that (i) subjects generally should be told of the personal characteristics of researchers when relevant as part of the researchers’ job and (ii) that subjects should be told of researchers’ views when conceptually connected to the research and (iii) that subjects should almost always be told about sponsorship. While the paper explicitly limits the role of informed consent, these recommendations go significantly beyond most guidelines in their requirements about what information should be disclosed. (shrink)

This article outlines challenges to benefitting developing countries that are hosts of international research. In the context of existing guidance and frameworks for benefit‐sharing, it aims to provoke dialog about socioeconomic factors and other background conditions that influence what constitute benefits in a given host setting, and about the proportionality between benefits to hosts and benefits to sponsors and researchers. It argues that capacity‐building for critical thinking and negotiation in many developing country governments, institutions, and communities is a benefit (...) because it can help to overcome background conditions that impinge on equitable international research negotiations, partnerships, and benefits. Enhancing the capacity for both critical thinking and negotiation can, like other targets of capacity‐building, nurture respectful and trusting partnerships that benefit all stakeholders in international research. (shrink)

There is an alleged tension between undue inducement and exploitation in research trials. This paper considers claims that increasing the benefits to research subjects enrolled in international, externally-sponsored clinical trials should be avoided on the grounds that it may result in the undue inducement of research subjects. This article contributes to the debate about exploitation versus undue inducement by introducing an analysis of the available empirical research into research participants' motivations and the influence of (...) payments on research subjects' behaviour and risk assessment. Admittedly, the available research in this field is limited, but the research that has been conducted suggests that financial rewards do not distort research subjects' behaviour or blind them to the risks involved with research. Therefore, I conclude that research sponsors should prioritise the prevention of exploitation in international research by providing greater benefits to research participants. (edited). (shrink)

Human Biological Materials are an invaluable resource in biomedical research. Objective To determine if researchers and a Research Ethics Committee at a South African institution addressed ethical issues pertaining to HBMs in collaborative research with developed countries. Study Design Ethically approved retrospective cross-sectional descriptive audit. Results Of the 1305 protocols audited, 151 fulfilled the study's inclusion criteria. Compared to other developed countries, a majority of sponsors were from the USA . The principle investigators in all 151 protocols (...) informed the REC of their intent to store HBMs. Only 132 protocols informed research participants . In 148 protocols informed consent was obtained from research participants, 116 protocols solicited broad consent compared to specific consent [p < 0.0001]. In 105 cases a code was used to maintain confidentiality. HBMs were anonymised in 14 protocols [p < 0.0001]. More protocols informed the REC than the research participants that HBMs would be exported . Export permits and Material Transfer Agreements were not available in 109 and 143 protocols, respectively. Conclusions Researchers and the REC did not adequately address the inter-related ethical and regulatory issues pertaining to HBMs. There was a lack of congruence between the ethical guidelines of developed countries and their actions which are central to the access to HBMs in collaborative research. HBMs may be leaving South Africa without EPs and MTAs during the process of international collaborative research. (shrink)

Human Biological Materials (HBMs) are an invaluable resource in biomedical research.ObjectiveTo determine if researchers and a Research Ethics Committee (REC) at a South African institution addressed ethical issues pertaining to HBMs in collaborative research with developed countries.Study DesignEthically approved retrospective cross‐sectional descriptive audit.ResultsOf the 1305 protocols audited, 151 (11.57%) fulfilled the study's inclusion criteria. Compared to other developed countries, a majority of sponsors (90) were from the USA (p = 0.0001). The principle investigators (PIs) in all 151 (...) protocols informed the REC of their intent to store HBMs. Only 132 protocols informed research participants (P < 0.0001). In 148 protocols informed consent (IC) was obtained from research participants, 116 protocols (76.8%) solicited broad consent compared to specific consent (32; 21.2%) [p < 0.0001]. In 105 cases a code was used to maintain confidentiality. HBMs were anonymised in 14 protocols [p < 0.0001]. More protocols informed the REC (90) than the research participants (67) that HBMs would be exported (p = 0.011). Export permits (EPs) and Material Transfer Agreements (MTAs) were not available in 109 and 143 protocols, respectively.ConclusionsResearchers and the REC did not adequately address the inter‐related ethical and regulatory issues pertaining to HBMs. There was a lack of congruence between the ethical guidelines of developed countries and their actions which are central to the access to HBMs in collaborative research. HBMs may be leaving South Africa without EPs and MTAs during the process of international collaborative research. (shrink)

Imagine a study in which HIV-infected pregnant women are given antiretroviral treatment to determine how effectively it will prevent HIV transmission during childbirth. Each mother’s involvement in this study ends with the birth of her child, at which time her access to antiretrovirals provided by the study also ceases. At the outset of the study, the investigator and sponsor agree that after the child’s birth, they will refer mothers who require treatment for their HIV to a national program that provides (...) antiretroviral treatment and care. Assuming the Institutional Review Board raises no objections to this plan, should the research team consider their ethical obligations to participants fulfilled? If the investigator and sponsor were to consult the Common Rule, they would find little to suggest that there are any further ethical issues to address. (shrink)

Background: Financial conflict of interest in clinical research is an area of active debate. While data exist on the perspectives and roles of academic institutions, investigators, industry sponsors, and scientific journals, little is known about the perspectives of potential research participants.Methods: The authors surveyed potential research participants over the internet, using the Harris Interactive Chronic Illness Database. A potential research participant was defined by: self report of diagnosis by a health care professional and willingness to participate (...) in clinical trials. Email invitations were sent to 20 205 persons with coronary artery disease, breast cancer, or depression; a total of 6363 persons were screened; of these, 86% or 5478 met inclusion criteria and completed the survey. The outcome measures were respondents’ ratings on: importance of knowing conflict of interest information, whether its disclosure ought to be required, and its effect on willingness to participate—across seven widely discussed scenarios of financial conflicts of interest .Results: Majority responded that knowing conflict of interest information was “extremely” or “very” important; a larger majority felt financial conflicts of interest should be disclosed as part of informed consent . In all seven scenarios, a majority was still willing to participate but in some scenarios a sizable minority would be wary of participation. Respondents were more wary of individual than institutional conflicts of interest. Illness group and sociodemographic factors had modest effects and did not affect the main trends.Conclusions: The prevailing practice of non-disclosure of financial conflicts of interest in clinical research appears contrary to the values of potential research participants. (shrink)

People engaged in international research projects – whether sponsors, researchers or participants – have different cultural and religious backgrounds. This can lead to quandaries over whose values should dictate the ethical basis for research. This paper addresses this issue by claiming that four core values are integral to the nature and justification of valid research and that to have integrity researchers must be committed to these values. Since the values are not specific to any particular culture or (...) religion they constitute a neutral ethical framework for the conduct of international research. It then claims that if researchers understand these values they can take responsibility for applying them to their own situation. This can help overcome problems which currently arise when researchers are not certain what to do because the specific ethical requirements of sponsors would be impractical or damaging if implemented in the circumstances in which the researchers operate. Finally, it is suggested that the four values outlined in the paper may be a basis for further work – such as developing awareness training and evolving guidance for specialist areas of research. (shrink)